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Abstract:

Devices and methods for restructure and stabilization of a fractured or
weakened head of a bone are disclosed herein. A device includes a
delivery catheter having a proximal end and a distal end, an inner void
for passing at least one light sensitive liquid, and an inner lumen; an
expandable member releasably engaging the distal end of the delivery
catheter; and a light conducting fiber sized to pass through the inner
lumen of the delivery catheter and into the expandable member. The
expandable member moves from a deflated state to an inflated state when
the light sensitive liquid is passed to the expandable member. When the
light conducting fiber is in the expandable member, the light conducting
fiber is able to disperse the light energy to initiate hardening of the
light sensitive liquid within the expandable member to form a
photodynamic implant.

Claims:

1. A device for restructuring or stabilizing a fractured or weakened head
of a bone comprising: a delivery catheter having an elongated shaft with
a proximal end, a distal end, and a longitudinal axis therebetween, an
inner void for passing at least one light sensitive liquid, and an inner
lumen; an expandable member releasably engaging the distal end of the
delivery catheter, the expandable member capable of moving from a
deflated state to an inflated state when the at least one light sensitive
liquid is passed to the expandable member, wherein the expandable member
is sufficiently designed to be at least partially placed into a space
within a head of a bone; and a light conducting fiber sized to pass
through the inner lumen of the delivery catheter and into the expandable
member, wherein, when the light conducting fiber is in the expandable
member, the light conducting fiber is able to disperse the light energy
to initiate hardening of the at least one light sensitive liquid within
the expandable member to form a photodynamic implant.

2. The device of claim 1, wherein the expandable member has a pear shape,
bulb shape, dome shape, rounded shape, or elongated shape.

3. The device of claim 1, wherein the expandable member has a tapered
elongated shape.

4. The device of claim 1, wherein the expandable member has a retrograde
shape or an antegrade shape.

5. The device of claim 1, wherein the expandable member has a proximal
end and a distal end, and the diameter of the proximal end of the
expandable member is larger than the diameter of the distal end of the
expandable member.

6. The device of claim 1, wherein the expandable member has a proximal
end and a distal end, and the diameter of the distal end of the
expandable member is larger than the diameter of the proximal end of the
expandable member.

7. The device of claim 1, wherein the expandable member is sufficiently
designed to be contained within a head of a bone.

8. The device of claim 1, wherein the expandable member includes a head
section and a shaft section, and the expandable member is sufficiently
designed such that the head section can be placed within a head of a bone
and the shaft section can extend for a length into a shaft of the bone.

9. The device of claim 1, wherein the photodynamic implant is configured
to engage with at least one bone fixation implant.

10. The device of claim 9, wherein the at least one bone fixation implant
is a screw, rod, pin, nail, or combination thereof.

11. The device of claim 1, wherein the light conducting fiber includes a
core and a cladding disposed on the core, and the cladding has at least
one cut therein to expose the core and configured to alter the light
exuded from the light conducting fiber.

12. A kit for repairing or stabilizing a fractured or weakened head of a
bone comprising: a light conducting fiber; at least one light sensitive
liquid; a delivery catheter having an elongated shaft with a proximal
end, a distal end, and a longitudinal axis therebetween, an inner void,
and an inner lumen; and an expandable member releasably engaging the
distal end of the delivery catheter, wherein the expandable member is
sufficiently designed to be at least partially placed into a space within
a head of a bone, and wherein the delivery catheter has an inner void for
passing the at least one light sensitive liquid into the expandable
member, and an inner lumen for passing the light conducting fiber into
the expandable member.

13. The kit of claim 12, further comprising a plurality of expandable
members of different sizes or shapes.

14. The kit of claim 12, further comprising a light source.

15. A method for repairing or stabilizing a fractured or weakened head of
a bone comprising: placing an expandable member removably attached to a
distal end of a delivery catheter at least partially into a space within
a head of a bone; infusing a light sensitive liquid into the expandable
member through an inner lumen of the delivery catheter; inserting a light
conducting fiber into the expandable member through an inner void of the
delivery catheter; and activating the light conducting fiber to cure the
light sensitive liquid inside the expandable member to form a
photodynamic implant inside the head of the bone.

16. The method of claim 15, wherein the expandable member has a tapered
elongated shape.

17. The method of claim 15, further comprising disposing a head section
of the expandable member within a head of a bone and extending a shaft
section of the expandable member for a length into the shaft of the bone.

18. The method of claim 15, further comprising engaging the photodynamic
implant with at least one bone fixation implant.

19. The method of claim 15, wherein the at least one bone fixation
implant is a screw, rod, pin, nail, or combination thereof

20. The method of claim 15, wherein the bone is a femur or a humerus.

Description:

RELATED APPLICATIONS

[0001] This application claims the benefit of and priority to U.S.
Provisional Patent Application No. 61/509,391, filed on Jul. 19, 2011,
U.S. Provisional Patent Application No. 61/509,314, filed on Jul. 19,
2011, and U.S. Provisional Patent Application No. 61/509,459, filed on
Jul. 19, 2011, the entirety of these applications are hereby incorporated
herein by reference.

FIELD

[0002] The embodiments disclosed herein relate to bone implants, and more
particularly to devices and methods for bone restructure and
stabilization.

BACKGROUND

[0003] Bones form the skeleton of the body and allow the body to be
supported against gravity and to move and function in the world. Bone
fractures can occur, for example, from an outside force or from a
controlled surgical cut (an osteotomy). A fracture's alignment is
described as to whether the fracture fragments are displaced or in their
normal anatomic position. In some instances, surgery may be required to
re-align and stabilize the fractured bone. But proper positioning and
alignment of a bone is difficult to achieve. It would be desirable to
have an improved device or method for stabilizing, positioning, and
repairing a fractured or weakened bone.

SUMMARY

[0004] Devices and methods for bone restructure and stabilization are
disclosed herein. According to aspects illustrated herein, there is
provided a device for repairing or stabilizing a fractured or weakened
head of a bone that includes a delivery catheter having an elongated
shaft with a proximal end, a distal end, and a longitudinal axis
therebetween, the delivery catheter having an inner void for passing at
least one light sensitive liquid, and an inner lumen; an expandable
member releasably engaging the distal end of the delivery catheter, the
expandable member moving from a deflated state to an inflated state when
the at least one light sensitive liquid is passed to the expandable
member, wherein the expandable member is sufficiently designed to be at
least partially placed into a space within a head of a bone; and a light
conducting fiber sized to pass through the inner lumen of the delivery
catheter and into the expandable member, wherein, when the light
conducting fiber is in the expandable member, the light conducting fiber
is able to disperse the light energy to initiate hardening of the at
least one light sensitive liquid within the expandable member, forming a
photodynamic implant of the present disclosure. In an embodiment, the
expandable member is sufficiently designed to be contained within a head
of a bone. In an embodiment, the expandable member is sufficiently
designed such that a head section of the expandable member is within a
head of a bone and a shaft section of the expandable member extends for a
length into the shaft of the bone.

[0005] In an embodiment, a photodynamic implant of the present disclosure
acts as a mandrel or form over which fragments of a head of a bone can be
arranged to a substantially original position. In an embodiment, a
photodynamic implant acts as a filler to return a head of a bone
substantially to its original, anatomical shape prior to fracture or
breaking In an embodiment, a photodynamic implant of the present
disclosure is used for reattaching bone fragments of a head of a bone
separated from the bone. In an embodiment, a photodynamic implant of the
present disclosure is used for fixating a head of a bone separated from
the bone. In an embodiment, a photodynamic implant of the present
disclosure is used to re-align fragments of a broken bone to promote
fracture restructure and stabilization. In an embodiment, a photodynamic
implant of the present disclosure provides support and stability to a
fractured or weakened bone during the natural healing process of the
bone. In an embodiment, a photodynamic implant of the present disclosure
is used to provide added strength to a weakened bone.

[0006] In an embodiment, a photodynamic implant of the present disclosure
is configured to engage with another implant, including, but not limited
to, a metal screw, rod, pin or nail. In an embodiment, a photodynamic
implant of the present disclosure provides means to secure, bolt and pull
the fractured bone segments back together into position. In an
embodiment, a photodynamic implant of the present disclosure is used to
fill a space within a fractured bone to return the fractured bone to its
anatomical shape and is engaged to another implant that provides strength
and stability to the shape. In an embodiment, a photodynamic implant of
the present disclosure is configured to receive bone screws such that
compressive force is exerted on bone fragments supported by the
photodynamic implant.

[0007] In an embodiment, a photodynamic implant of the present disclosure
is configured to fill interstitial space between a bone fixation implant
and cortical bone to distribute load more evenly across the bone
interface. That is, a photodynamic implant of the present disclosure acts
as a filler between a bone fixation implant and a cortical bone interface
so that load is not transferred through focal contact points between the
bone fixation device and the cortical bone, but rather the load is
distributed throughout a conformal contact in the bone.

[0008] A device for restructuring or stabilizing a fractured or weakened
head of a bone is provided. The device includes: a delivery catheter
having an elongated shaft with a proximal end, a distal end, and a
longitudinal axis therebetween, an inner void for passing at least one
light sensitive liquid, and an inner lumen; an expandable member
releasably engaging the distal end of the delivery catheter; and a light
conducting fiber sized to pass through the inner lumen of the delivery
catheter and into the expandable member. The expandable member is capable
of moving from a deflated state to an inflated state when the at least
one light sensitive liquid is passed to the expandable member. The
expandable member is sufficiently designed to be at least partially
placed into a space within a head of a bone. When the light conducting
fiber is in the expandable member, the light conducting fiber is able to
disperse the light energy to initiate hardening of the at least one light
sensitive liquid within the expandable member to form a photodynamic
implant

[0009] In an embodiment, the expandable member has a pear shape, bulb
shape, dome shape, rounded shape, or elongated shape. In an embodiment,
the expandable member has a tapered elongated shape. In an embodiment,
the expandable member has a retrograde shape or an antegrade shape. In an
embodiment, the expandable member has a proximal end and a distal end,
and the diameter of the proximal end of the expandable member is larger
than the diameter of the distal end of the expandable member. In an
embodiment, the expandable member has a proximal end and a distal end,
and the diameter of the distal end of the expandable member is larger
than the diameter of the proximal end of the expandable member. In an
embodiment, the expandable member is sufficiently designed to be
contained within a head of a bone. In an embodiment, the expandable
member includes a head section and a shaft section, and the expandable
member is sufficiently designed such that the head section can be placed
within a head of a bone and the shaft section can extend for a length
into a shaft of the bone.

[0010] In an embodiment, the photodynamic implant is configured to engage
with at least one bone fixation implant. In an embodiment, the at least
one bone fixation implant is a screw, rod, pin, nail, or combination
thereof. In an embodiment, the light conducting fiber includes a core and
a cladding disposed on the core, and the cladding has at least one cut
therein to expose the core and configured to alter the light exuded from
the light conducting fiber.

[0011] In one aspect, a kit for repairing or stabilizing a fractured or
weakened head of a bone includes: a light conducting fiber; at least one
light sensitive liquid; a delivery catheter having an elongated shaft
with a proximal end, a distal end, and a longitudinal axis therebetween,
an inner void, and an inner lumen; and an expandable member releasably
engaging the distal end of the delivery catheter. The expandable member
is sufficiently designed to be at least partially placed into a space
within a head of a bone. The delivery catheter has an inner void for
passing the at least one light sensitive liquid into the expandable
member, and an inner lumen for passing the light conducting fiber into
the expandable member. In an embodiment, the kits includes a plurality of
expandable members of different sizes or shapes. In an embodiment, the
kit includes a light source.

[0012] In one aspect, a method for repairing or stabilizing a fractured or
weakened head of a bone includes: placing an expandable member removably
attached to a distal end of a delivery catheter at least partially into a
space within a head of a bone; infusing a light sensitive liquid into the
expandable member through an inner lumen of the delivery catheter;
inserting a light conducting fiber into the expandable member through an
inner void of the delivery catheter; and activating the light conducting
fiber to cure the light sensitive liquid inside the expandable member to
form a photodynamic implant inside the head of the bone. In an
embodiment, the expandable member has a tapered elongated shape.

[0013] In an embodiment, the method includes disposing a head section of
the expandable member within a head of a bone and extending a shaft
section of the expandable member for a length into the shaft of the bone.
In an embodiment, the method includes engaging the photodynamic implant
with at least one bone fixation implant. In an embodiment, the at least
one bone fixation implant is a screw, rod, pin, nail, or combination
thereof. In an embodiment, the bone is a femur or a humerus.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The presently disclosed embodiments will be further explained with
reference to the attached drawings, wherein like structures are referred
to by like numerals throughout the several views. The drawings shown are
not necessarily to scale, with emphasis instead generally being placed
upon illustrating the principles of the presently disclosed embodiments.

[0015] FIG. 1A shows a schematic illustration of an embodiment of a bone
implant system of the present disclosure. The system includes a light
source, a light pipe, an attachment system, a light-conducting fiber, a
light-sensitive liquid, a delivery catheter and an expandable member
sufficiently shaped to fit within a space or a gap in a fractured bone.

[0016]FIG. 1B and FIG. 1c show schematic illustrations of embodiments of
a bone implant device that includes a delivery catheter and an expandable
member sufficiently shaped to fit within a space or a gap in a fractured
bone.

[0017] FIG. 2A and FIG. 2B show close-up cross-sectional views of the
region circled in FIG. 1A. FIG. 2A shows a cross-sectional view of a
distal end of the delivery catheter and the expandable member prior to
the device being infused with light-sensitive liquid. FIG. 2B shows a
cross-sectional view of the distal end of the delivery catheter and the
expandable member after the device has been infused with light-sensitive
liquid and light energy from the light-conducting fiber is introduced
into the delivery catheter and inner lumen of the expandable member to
cure the light-sensitive liquid.

[0018]FIG. 2c and FIG. 2D show a close-up cross-sectional view of the
regions circled in FIG. 1B and FIG. 1c, respectively. FIG. 2c and FIG. 2D
show a cross-sectional view of a distal end of the delivery catheter and
the expandable member and a light-conducting fiber in the delivery
catheter and inner lumen of the expandable member.

[0019] FIG. 3A illustrates a cross-section view of an embodiment of a
device in a cavity of a bone prior to inflation of the expandable member.

[0020]FIG. 3B illustrates a cross-section view of an embodiment of a
device in a cavity of a bone after inflation of the expandable member.

[0021]FIG. 4A and FIG. 4B show schematic illustrations of embodiments of
an expandable member.

[0022]FIG. 5 is a schematic illustration of an embodiment of a
photodynamic implant of the present disclosure.

[0023]FIG. 6 illustrates a cross-sectional view of an embodiment of a
device being inserted into a cavity of bone using the disclosed devices
and methods.

[0024]FIG. 7 shows a cross-sectional view of an embodiment of a device
for treating a fractured or weakened head of a femur using the disclosed
methods.

[0025] While the above-identified drawings set forth presently disclosed
embodiments, other embodiments are also contemplated, as noted in the
discussion. This disclosure presents illustrative embodiments by way of
representation and not limitation. Numerous other modifications and
embodiments can be devised by those skilled in the art which fall within
the scope and spirit of the principles of the presently disclosed
embodiments.

DETAILED DESCRIPTION

[0026] Devices and methods for bone restructure and stabilization are
disclosed herein. In an embodiment, the present disclosure is directed to
devices and methods for human treatment of bone fractures. In an
embodiment, the present disclosure is directed to devices and methods for
veterinary treatment of a fractured or a weakened bone. In an embodiment,
devices and methods are provided for restructure, alignment and
stabilization of a bone having a rounded head. The devices of the present
disclosure are suitable to treat any fractured or weakened bone
including, but not limited to, tibia, femur, fibula, humerus, ulna,
radius, metatarsals, metacarpals, phalanx, phalanges, ribs, spine,
vertebrae, clavicle, pelvis, wrist, mandible, and other bones. In an
embodiment, a bone implant system of the present disclosure is used to
treat a fractured or weakened proximal humerus. In an embodiment, a bone
implant system of the present disclosure is used to treat a fractured or
weakened femoral head.

[0027] As used herein, the terms "fracture" or "fractured bone" refer to a
partial or complete break in the continuity of a bone. The fracture can
occur, for example, from an outside force or from a controlled surgical
cut (osteotomy). The presently disclosed embodiments can be used to treat
any type of bone fracture, including, but not limited to, a displaced
fracture, a non-displaced fracture, an open fracture, a closed fracture,
a hairline fracture, a compound fracture, a simple fracture, a
multi-fragment fracture, a comminuted fracture, an avulsion fracture, a
buckle fracture, a compacted fracture, a stress fracture, a compression
fracture, spiral fracture, butterfly fracture, other fractures as
described by AO Foundation coding, multiple fractures in a bone, and
other types of fractures.

[0028] As used herein, the term "weakened bone" refers to a bone with a
propensity toward a fracture due to a decreased strength or stability due
to a disease or trauma. Some bone diseases that weaken the bones include,
but are not limited to, osteoporosis, achondroplasia, bone cancer,
fibrodysplasia ossificans progressiva, fibrous dysplasia, legg calve
perthes disease, myeloma, osteogenesis imperfecta, osteomyelitis,
osteopenia, osteoporosis, Paget's disease, and scoliosis. Weakened bones
are more susceptible to fracture, and treatment to prevent bone fractures
may be desirable.

[0029] As used herein, the term "photodynamic implant" refers to an
expandable member of the present disclosure that is infused with a
photodynamic (light curable) material and exposed to an appropriate
frequency of light and intensity to cure the material inside the
expandable member and form a rigid structure.

[0030] As used herein, the terms "bone restructuring" or "restructure"
refer to positioning a fractured bone back to a substantially normal,
anatomically-correct position (separation of the bone fragments) and/or
shape as well as supporting or stabilizing a weakened bone. In an
embodiment, a photodynamic implant of the present disclosure provides a
template, mandrel or form for restructuring a fractured or weakened bone.
That is, a photodynamic implant of the present disclosure acts as a
template, mandrel or form over which the fragments of a fractured bone
can be arranged to a substantially original position and/or to which the
fragments can be secured in a substantially original position. In an
embodiment, a photodynamic implant of the present disclosure acts as a
template, mandrel or form to return a broken bone to its a substantially
normal, anatomically-correct shape. In an embodiment, a photodynamic
implant of the present disclosure acts as a template, mandrel or form to
support or stabilize a weakened bone in its a substantially normal,
anatomically-correct shape. In an embodiment, a photodynamic implant of
the present disclosure is used to restructure a fractured bone by aiding
in attachment of a broken-off portion of a bone to the intact portion of
the bone. In an embodiment, a photodynamic implant of the present
disclosure is used to add strength to a weakened bone to prevent further
weakening or a potential fracture.

[0031] In an embodiment, the present device is used in a minimally
invasive surgical procedure. The device can enter a minimally invasive
incision or access hole of any suitable size. For example, the access
hole is about 5 mm to about 6 mm in diameter or any other suitable
dimensions. In an embodiment, an expanding reamer or burr is used to pass
through the small access hole. When inserted, the reamer is opened up to
create a larger hole in the bone.

[0032] FIG. 1A shows a schematic illustration of an embodiment of a bone
implant system 100. As shown in FIG. 1A, the system 100 includes a light
source 110, a light pipe 120, an attachment system 130 and a
light-conducting fiber 140. The attachment system 130 communicates light
energy from the light source 110 to the light-conducting fiber 140. In an
embodiment, the light source 110 emits frequency that corresponds to a
band in the vicinity of 390 nm to 770 nm, the visible spectrum. In an
embodiment, the light source 110 emits frequency that corresponds to a
band in the vicinity of 410 nm to 500 nm. In an embodiment, the light
source 110 emits frequency that corresponds to a band in the vicinity of
430 nm to 450 nm. The system 100 further includes a flexible delivery
catheter 150 having a proximal end that includes at least two ports and a
distal end terminating in an expandable member 170. The expandable member
170 of FIG. 1A has a bulbous shape, but may have any other suitable
shape.

[0033]FIG. 1B and FIG. 1c show schematic illustrations of embodiments of
a bone implant device. The devices include a delivery catheter 150 and an
expandable member 170 sufficiently shaped to fit within a space or a gap
in a fractured bone. The expandable members 170 of FIG. 1B and FIG. 1c
have a tapered elongated shape to fill the space or gap in certain
fractured or weakened bones to be repaired or stabilized. In an
embodiment, the expandable member 170 has an antegrade shape as shown in
FIG. 1B. In an embodiment, the expandable member 170 has a retrograde
shape as shown in FIG. 1c. In FIG. 1B, the expandable member 170 has a
larger diameter at its distal end than the proximal end. In FIG. 1c, the
expandable member 170 has a larger diameter at its proximal end than the
distal end.

[0034] In an embodiment, the maximum diameter of the larger portion of the
expandable member 170 is at least 1.5 times larger than the maximum
diameter of the smaller portion of the expandable member 170. In an
embodiment, the maximum diameter of the larger portion of the expandable
member 170 is at least two times larger than the maximum diameter of the
smaller portion of the expandable member 170.

[0035] In an embodiment, shown in FIG. 1B, the maximum diameter of the
proximal portion of the expandable member 170 is at least 1.5 times the
maximum diameter of the distal portion of the expandable member 170. In
an embodiment, the maximum diameter of the proximal portion of the
expandable member 170 is at least two times the maximum diameter of the
distal portion of the expandable member 170.

[0036] In an embodiment, shown in FIG. 1c, the maximum diameter of the
distal portion of the expandable member 170 is at least 1.5 times the
maximum diameter of the proximal portion of the expandable member 170. In
an embodiment, the maximum diameter of the distal portion of the
expandable member 170 is at least two times the maximum diameter of the
proximal portion of the expandable member 170.

[0037] The various shapes of the expandable member 170 allow for different
approaches during minimally invasive surgical treatment of weakened or
fractured bones. For example, an expandable member 170 having a
retrograde or antegrade shape can be used for repair of a weakened or
fractured proximal humerus. The antegrade shape allows for placement of
the portion of the expandable member 170 with the largest diameter at the
bone location most in need of repair or stabilization, including above
and below the surgical neck area. For example, in the case of a proximal
humerus, the antegrade shape allows for an incision and entry point into
the humeral head through or just lateral to the rotator cuff. The
geometry of the retrograde shape is opposite to the antegrade shape. With
the retrograde shape, the portion of the expandable member 170 with the
largest diameter is placed at the distal end of the catheter 150. The
retrograde shaped expandable member 170 having the largest diameter can
be placed at the bone location most in need of repair or stabilization,
including above and below the surgical neck area. When repairing a
proximal humerus, the retrograde shape allows for distal placement
through an incision and bone entry point at (1) the medial or lateral
epicondyles or (2) between these condyles at the roof of the olecranon
fossa. In an embodiment, a device includes a retrograde shape expandable
member 170 and has a longer catheter 150 (for example, about 3-4 inches
longer) due to the increased distance from the bone access hole to the
surgical neck.

[0038] In an embodiment, the expandable member 170 is sufficiently shaped
to fit within a space or a gap in a fractured or weakened bone. One or
more radiopaque markers, bands or beads may be placed at various
locations along the expandable member 170 and/or the flexible delivery
catheter 150 so that components of the system 100 may be viewed using
fluoroscopy.

[0039] In the embodiments shown in FIG. 1A, FIG. 1B, and FIG. 1c, the
proximal end of the delivery catheter 150 includes a first port 162 and a
second port 164. The first port 162 can accept, for example, the
light-conducting fiber 140. The second port 164 can accept, for example,
a syringe 160 housing a light-sensitive liquid 165. In an embodiment, the
syringe 160 maintains a low pressure during the infusion and aspiration
of the light-sensitive liquid 165. In an embodiment, the syringe 160
maintains a low pressure of about 10 atmospheres or less during the
infusion and aspiration of the light-sensitive liquid 165. In an
embodiment, the syringe 160 maintains a low pressure of less than about 5
atmospheres during the infusion and aspiration of the light-sensitive
liquid 165. In an embodiment, the syringe 160 maintains a low pressure of
about 4 atmospheres or less during the infusion and aspiration of the
light-sensitive liquid 165. In an embodiment, the light-sensitive liquid
165 is a photodynamic (light-curable) monomer. In an embodiment, the
photodynamic (light-curable) monomer is exposed to an appropriate
frequency of light and intensity to cure the monomer inside the
expandable member 170 and form a rigid structure. In an embodiment, the
photodynamic (light-curable) monomer 165 is exposed to electromagnetic
spectrum that is visible (frequency that corresponds to a band in the
vicinity of 390 nm to 770 nm). In an embodiment, the photodynamic
(light-curable) monomer 165 is radiolucent, which permit x-rays to pass
through the photodynamic (light-curable) monomer 165. In an embodiment,
the delivery catheter 150 has one or more ports.

[0040] FIG. 2A and FIG. 2B show close-up cross-sectional views of the
region circled in FIG. 1. FIG. 2A shows a cross-sectional view of a
distal end of the delivery catheter 150 and the expandable member 170
prior to the device being infused with light-sensitive liquid. FIG. 2B
shows a cross-sectional view of the distal end of the delivery catheter
150 and the expandable member 170 after the device has been infused with
light-sensitive liquid and light energy from the light-conducting fiber
is introduced into the delivery catheter 150 and inner lumen of the
expandable member 170 to cure the light-sensitive liquid.

[0041] As illustrated in FIG. 2A and FIG. 2B, the flexible delivery
catheter 150 includes an inner void 152 for passage of the
light-sensitive liquid 165, and an inner lumen 154 for passage of the
light-conducting fiber 140. In the embodiment illustrated in FIG. 2A and
FIG. 2B, the inner lumen 154 and the inner void 152 are concentric to one
another. The light-sensitive liquid 165 has a low viscosity or low
resistance to flow, to facilitate the delivery of the light-sensitive
liquid 165 through the inner void 152. In an embodiment, the
light-sensitive liquid 165 has a viscosity of about 1000 cP or less. In
an embodiment, the light-sensitive liquid 165 has a viscosity ranging
from about 650 cP to about 450 cP. The expandable member 170 may be
inflated, trial fit and adjusted as many times as a user wants with the
light-sensitive liquid 165, up until the light source 110 is activated,
when the polymerization process is initiated. Because the light-sensitive
liquid 165 has a liquid consistency and is viscous, the light-sensitive
liquid 165 may be delivered using low pressure delivery and high pressure
delivery is not required, but may be used.

[0042]FIG. 2c and FIG. 2D show a close-up cross-sectional view of the
region circled in FIG. 1B and FIG. 1c, respectively. FIG. 2c and FIG. 2D
show cross-sectional views of a distal end of the delivery catheter 150
and the expandable member 170 and a light-conducting fiber 140 in the
delivery catheter 150 and inner lumen of the expandable member 170. The
device also has a separation area 172 at the junction of the delivery
catheter 150 and the expandable member 170 where the delivery catheter
150 may be separated from the expandable member 170.

[0043] In an embodiment, a contrast material may be added to the
light-sensitive liquid 165 without significantly increasing the
viscosity. Contrast materials include, but are not limited to, barium
sulfate, tantalum, or other contrast materials known in the art. The
light-sensitive liquid 165 can be introduced into the proximal end of the
flexible delivery catheter 150 and passes within the inner void 152 of
the flexible delivery catheter 150 up into an inner cavity 172 of the
expandable member 170 to change a thickness of the expandable member 170
without changing a width or depth of the expandable member 170. In an
embodiment, the light-sensitive liquid 165 is delivered under low
pressure via the syringe 160 attached to the second port 164. The
light-sensitive liquid 165 can be aspirated and reinfused as necessary,
allowing for thickness adjustments to the expandable member 170 prior to
activating the light source 110 and converting the liquid monomer 165
into a hard polymer.

[0044] In an embodiment, the light-sensitive liquid may be provided as a
unit dose. As used herein, the term "unit dose" is intended to mean an
effective amount of light sensitive liquid adequate for a single session
or treatment. By way of a non-limiting example, a unit dose of a light
sensitive liquid of the present disclosure for expanding the expandable
member 170 may be defined as enough light-sensitive liquid to expand the
expandable member 170 to a desired shape and size. In an embodiment, the
expandable member 170 is sufficiently shaped and sized to fit within a
space or a gap in a fractured bone. The desired shape and size of the
expandable member 170 may vary somewhat from patient to patient. Thus, a
user using a unit dose may have excess light-sensitive liquid left over
after the procedure. It is desirable to provide sufficient amount of
light-sensitive liquid to accommodate even the above-average patient. In
an embodiment, a unit dose of a light-sensitive liquid of the present
disclosure is contained within a container.

[0045] In an embodiment, a unit dose of a light-sensitive liquid of the
present disclosure is contained in an ampoule. In an embodiment, the
light-sensitive liquid can be delivered under low pressure via a standard
syringe attached to the second port 164. In an embodiment, the
light-sensitive liquid can be delivered without use of a pump.

[0046] As illustrated in FIG. 1A in conjunction with FIG. 2B, the
light-conducting fiber 140 can be introduced into the proximal end of the
flexible delivery catheter 150 via the first port 162 and passes within
the inner lumen 154 of the flexible delivery catheter 150 up into the
expandable member 170. The light-conducting fiber 140 is used in
accordance to communicate energy in the form of light from the light
source 110 to a remote location. The light-sensitive liquid 165 remains a
liquid monomer until activated by the light-conducting fiber 140 (cures
on demand). Radiant energy from the light source 110 is absorbed and
converted to chemical energy to polymerize the monomer. The
light-sensitive liquid 165, once exposed to the correct frequency light
and intensity, is converted into a hard polymer, resulting in a rigid
structure or photodynamic implant of the present disclosure. The monomer
may cure in any amount of time. In an embodiment, the monomer in the
light sensitive liquid 165 cures in about five seconds to about five
minutes. This cure affixes the expandable member 170 in an expanded shape
to form a photodynamic implant of the present disclosure. A cure may
refer to any chemical, physical, and/or mechanical transformation that
allows a composition to progress from a form (e.g., flowable form) that
allows it to be delivered through the inner void 162 in the flexible
delivery catheter 150, into a more permanent (e.g., cured) form for final
use in vivo. For example, "curable" may refer to uncured light-sensitive
liquid 165, having the potential to be cured in vivo (as by catalysis or
the application of a suitable energy source), as well as to a
light-sensitive liquid 165 in the process of curing (e.g., a composition
formed at the time of delivery by the concurrent mixing of a plurality of
composition components).

[0047] Light-conducting fibers use a construction of concentric layers for
optical and mechanical advantages. Suitable light-conducting fiber 140
can be made from any material, including, but not limited to, glass,
silicon, silica glass, quartz, sapphire, plastic, combinations of
materials, or any other material, and may have any diameter. In an
embodiment, the light-conducting fiber may be made from a polymethyl
methacrylate core with a transparent polymer cladding. The
light-conducting fiber 140 has any suitable diameter. In an embodiment,
the light-conducting fiber has a diameter between approximately 0.75 mm
and approximately 2.0 mm. In some embodiments, the light-conducting fiber
can have a diameter of about 0.75 mm, about 1 mm, about 1.5 mm, about 2
mm, less than about 0.75 mm or greater than about 2 mm.

[0048] In an embodiment, one or more light conducting fibers 140 are used.
Using more than one light conducting fibers 140 may reduce the cure time
of the light-sensitive liquid, particularly when used with larger
expandable members 170. In an embodiment, a plurality of light conducting
fibers 140 are positioned side-by-side or in parallel in the expandable
member 170. In an embodiment, a plurality of light conducting fibers 140
are positioned serially with ends of adjacent light conducting fibers 140
aligned or abutting on another in an end to end fashion. For example, one
light conducting fiber may be positioned in the distal portion of the
expandable member and another light conducting fiber may be positioned in
the proximal portion of the expandable member 170. In an embodiment, a
plurality of light conducting fibers are positioned in a combination of
parallel and serial positions, such as partially overlapping or any other
suitable configuration. In an embodiment, a plurality of light conducting
fibers can be attached to a single light source with a splitter, or can
be attached to a plurality of light sources.

[0049] In an embodiment, when a plurality of light conducting fibers 140
are used, an inner lumen of a delivery catheter 150 has a larger inner
diameter. In an embodiment, an inner lumen of the delivery catheter 150
has an inner diameter of about 1.8 mm. In an embodiment, an inner lumen
of the delivery catheter is sized to contain a plurality of light
conducting fibers 140. In an embodiment, a delivery catheter sized to
contain a plurality of light conducting fibers 140 has an inner diameter
of about 2.3 mm to about 3.0 mm.

[0050] In an embodiment, the light-conducting fiber 140 is made from a
polymethyl methacrylate core with a transparent polymer cladding. It
should be appreciated that the above-described characteristics and
properties of the light-conducting fibers 140 are exemplary and not all
embodiments of the present disclosure are intended to be limited in these
respects. Light energy from a visible emitting light source can be
transmitted by the light-conducting fiber 140. In an embodiment, visible
light having a wavelength spectrum of between about 380 nm to about 780
nm, between about 400 nm to about 600 nm, between about 420 nm to about
500 nm, between about 430 nm to about 440 nm or any other suitable
wavelengths, is used to cure the light-sensitive liquid.

[0051] The most basic function of a fiber is to guide light, i.e., to keep
light concentrated over longer propagation distances despite the natural
tendency of light beams to diverge, and possibly even under conditions of
strong bending. In the simple case of a step-index fiber, this guidance
is achieved by creating a region with increased refractive index around
the fiber axis, called the fiber core, which is surrounded by the
cladding. The cladding may be protected with a polymer coating. Light is
kept in the "core" of the light-conducting fiber by total internal
reflection. Cladding keeps light traveling down the length of the fiber
to a destination. In some instances, it is desirable to conduct
electromagnetic waves along a single guide and extract light along a
given length of the guide's distal end rather than only at the guide's
terminating face.

[0052] In some embodiments of the present disclosure, at least a portion
of a length of a light-conducting fiber is modified, e.g., by removing
the cladding, in order to alter the profile of light exuded from the
light-conducting fiber. The term "profile of light" refers to, without
limitation, direction, propagation, amount, intensity, angle of
incidence, uniformity, distribution of light and combinations thereof. In
an embodiment, the light-conducting fiber emits light radially in a
uniform manner, such as, for example, with uniform intensity, along a
length of the light-conducting fiber in addition to or instead of
emitting light from its terminal end/tip. To that end, all or part of the
cladding along the length of the light-conducting fiber may be removed.
It should be noted that the term "removing cladding" includes taking away
the cladding entirely to expose the light-conducting fiber as well as
reducing the thickness of the cladding. In addition, the term "removing
cladding" includes forming an opening, such as a cut, a notch, or a hole,
through the cladding. In an embodiment, removing all or part of the
cladding may alter the propagation of light along the light-conducting
fiber. In another embodiment, removing all or part of the cladding may
alter the direction and angle of incidence of light exuded from the
light-conducting fiber.

[0053]FIG. 1B, FIG. 1c, FIG. 2c, and FIG. 2D show an example of a
light-conducting fiber having a cut 141 in the cladding along the length
of the light-conducting fiber to modify light exuding from the
light-conducting fiber.

[0054] FIG. 3A illustrates an embodiment of a device in a cavity of a bone
314 prior to inflation of the expandable member 170. In an embodiment, as
shown in FIG. 3A, the cladding of the light-conducting fiber 140 is
removed by making a cut 141 in the cladding to expose the core of the
light-conducting fiber 140. In an embodiment, the cut 141 is a continuous
cut extending for the entire length of the modified section. In an
embodiment, the cut 141 includes multiple discontinuous cuts. In an
embodiment, the cladding is removed in such a way that a similar amount
of light is exuded along the modified section of the light-conducting
fiber. In another embodiment, the cladding is removed in such a way that
a different amount of light is exuded along the modified section of the
light-conducting fiber. In another embodiment, the cladding is removed in
such a way that the amount of light exuded along the modified section of
the light-conducting fiber decreases from the distal end of the modified
section of the light-conducting fiber toward the proximal end thereof. In
an embodiment, to alter the profile of the light exuded from the modified
section, the cuts in the cladding are located along the length of the
fiber in a spiral, as shown in FIG. 3A. In an embodiment, the pitch or
spacing between the cuts is varied along the length of the modified
section of the light-conducting fiber. In an embodiment, the spacing
between the cuts increases from the proximal end of the modified section
of the light-conducting fiber 140 to the distal end thereof such that the
amount of light exuded from the modified section of the light-conducting
fiber 140 progressively increases toward the distal end of the modified
section of the light-conducting fiber 140.

[0055]FIG. 3B is a schematic illustration showing an embodiment of an
expandable member 170 in the expanded state in a cavity of a bone 314. As
shown in FIG. 3B, the expandable member 170 is sufficiently designed for
placement into a space 310 within a head 312 of a bone 314, including,
but not limited to, a humerus or a femur. In an embodiment, the
expandable member 170 approximates the shape of the head 312 and is
configured to be placed within the head 312. In an embodiment, the
expandable member 170 is provided with shape and size to enable
reconstruction of the head 312. In an embodiment, the expandable member
170 can be pear-shaped, light-bulb shaped, or elongated. FIG. 3B shows an
example of an expandable member 170 that is elongated.

[0056] In an embodiment, the expandable member 170 includes a head section
302, i.e. an enlarged upper section, that merges into a shaft section
304, i.e. a tapered or frusto-conical lower section. In an embodiment,
the head section 302 tapers gradually to form the shaft section 304,
which can extend from the head 312 into a shaft 316 of the bone 314. In
an embodiment, the expandable member 170, including both the head section
302 and the shaft section 304, is configured to be contained in the space
310 within the head 312. In an embodiment, the shaft section 304 of the
expandable member 170 extends for any desired distance into the shaft 316
of the bone 314. In an embodiment, the shaft section 304 of the
expandable member 170 extends into the shaft 316 of the bone 314 for
about 50 mm to about 300 mm.

[0057]FIG. 4A and FIG. 4B show schematic illustrations of embodiments of
an expandable member 170. As shown in FIG. 4A, in an embodiment, the head
section 402 is dome-shaped or rounded. The bulbous shape of the head 412
has a diameter D1 that is larger than the diameter D2 of the shaft
section of the implant. In an embodiment, the diameter D1 of the head
section 402 is at least double the diameter D2 of the shaft section 404.
In an embodiment, the diameter D1 of the head section 402 is at least
triple the diameter D2 of the shaft section 404. In various embodiments,
the diameter D1 of the head section 402 is 2.5 times, 3.5 times, 4 times,
5 times, 10 times or more larger than the diameter D2 of the shaft
section 404. In an embodiment, the head section may be about 20 to 35 mm
in diameter at a distal part of the implant (for example, anatomically
the proximal head of the humerus), tapering in the frusto-conical shaft
section to 10 to 15 mm. In an embodiment, the shaft section 404 is
generally triangular or tapered. In an embodiment, the shaft section 404
is generally frusto-conical. The expandable member 170, including the
head section 402 and the shaft section 404, may be formed as a single
piece, or, alternatively, these sections can be mated to one another via
a screwed-in section, a through hole, or any other suitable mechanism.

[0058] As shown in FIG. 4B, in an embodiment, the shaft section 404 of the
expandable member 170 can include a transition portion 404a extending
from the head section 402 and an extension portion 404b extending
distally from the head 412 from the tapered portion 404a into the
intramedullary cavity. The transition portion 404a can be tapered or
frusto-conical and the extension portion can be either uniform or
tapered. In an embodiment, the diameter D2 of the transition portion 404
is substantially the same as the diameter D3 of the extension portion
404b. In an embodiment, the diameter D2 of the transition portion 404a is
1.5 times, 2 times, 3 times or more larger than the diameter D3 of the
extension portion 404b. In an embodiment, the diameter D1 of the head
section 402 is at least double the diameter D3 of the extension portion
404b of the shaft section 404. In an embodiment, the diameter D1 of the
head section 402 is at least triple the diameter D3 of the extension
portion 404b of the shaft section 404. In various embodiments, the
diameter D1 of the head section 402 is 2.5 times, 3.5 times, 4 times, 5
times, 10 times or more larger than the diameter D3 of the extension
portion 404b of the shaft section 404.

[0059] In an embodiment, the expandable member 170 can be round or oval
for placement into the space 410 within the head 412 of the bone 414. It
should be noted that the expandable member 170 may have any other shape
suitable for placement into a head of a bone. Suitable additional shapes
include, but are not limited to, a sphere, ovoid sphere, tapered cone,
three-dimensional wedge whereby one axis is significantly wider than the
other, with both tapering from a larger dimension to a smaller dimension,
and similar. As discussed above, the expandable member 170 can be a
tapered elongated shape such as an antegrade shape or a retrograde shape,
as shown in FIG. 1B and FIG. 1c, respectively.

[0060] In an embodiment, the external surface of the expandable member 170
is resilient and puncture resistant. In an embodiment, the expandable
member 170 is manufactured from a non-compliant
(non-stretch/non-expansion) conformable material including, but not
limited to, urethane, polyethylene terephthalate (PET), nylon elastomer
and other similar polymers. In an embodiment, the expandable member 170
is manufactured from a polyethylene terephthalate (PET). In an
embodiment, the expandable member 170 is manufactured from a radiolucent
material, which permit x-rays to pass through the expandable member 170.
In an embodiment, the expandable member 170 is manufactured from a
radiolucent polyethylene terephthalate (PET). In an embodiment, the
expandable member 170 is manufactured from a conformable compliant
material that is limited in dimensional change by embedded fibers. In an
embodiment, at least a portion of the external surface 174 of the
expandable member 170 is substantially even and smooth. In an embodiment,
at least a portion of the external surface of the expandable member 170
includes at least one textured element such as a bump, a ridge, a rib, an
indentation or any other shape. In an embodiment, at least a portion of
the external surface of the expandable member 170 protrudes out to form a
textured element. In an embodiment, at least a portion of the external
surface of the expandable member 170 invaginates to form a textured
element. In an embodiment, the textured element increases the friction
and improves the grip and stability of the expandable member 170 after
the expandable member 170 is inserted into the fracture location. In an
embodiment, the textured element results in increased interdigitation of
bone-device interface as compared to an expandable member without
textured elements. In an embodiment, the textured element can be convex
in shape. In an embodiment, the textured element can be concave in shape.
In an embodiment, the textured element can be circumferential around the
width of the expandable member 170, either completely or partially.

[0061] In general, bone graft or bone graft substitute can be used in
conjunction with an expandable member 170 of the present disclosure. In
an embodiment, the bone graft is an allogeneic bone graft. In an
embodiment, the bone graft is an autologous bone graft. In an embodiment,
the bone graft substitute is a hydroxyapatite bone substitute. In an
embodiment, a bone graft or bone graft substitute is used to fill in any
gaps that may exist, for example, between the external surface of the
expandable member 170 and the surfaces of the bone fragments. In an
embodiment, a bone graft or bone graft substitute is used to fill any
gaps that may exist, for example, between the textured element of the
expandable member 170 and the surfaces of the bone fragments.

[0062] In general, the expandable member 170 can include an external
surface that may be coated with materials including, but not limited to,
drugs (for example, antibiotics), proteins (for example, growth factors)
or other natural or synthetic additives (for example, radiopaque or
ultrasonically active materials). For example, after a minimally invasive
surgical procedure an infection may develop in a patient, requiring the
patient to undergo antibiotic treatment. An antibiotic drug may be added
to the external surface of the expandable member 170 to prevent or combat
a possible infection. Proteins, such as, for example, bone morphogenic
protein or other growth factors have been shown to induce the formation
of cartilage and bone. A growth factor may be added to the external
surface of the expandable member 170 to help induce the formation of new
bone. Due to the lack of thermal egress of the light-sensitive liquid 165
in the expandable member 170, the effectiveness and stability of the
coating is maintained.

[0063] In an embodiment, the expandable member 170 does not have any
valves. One benefit of not having valves is that the expandable member
170 may be expanded or reduced in size as many times as necessary to
assist in the fracture reduction and placement. Another benefit of the
expandable member 170 not having valves is the efficacy and safety of the
system 100. Since there is no communication passage of light-sensitive
liquid 165 to the body there cannot be any leakage of liquid 165 because
all the liquid 165 is contained within the expandable member 170. In an
embodiment, a permanent seal is created between the expandable member 170
and the delivery catheter 150 that is both hardened and affixed prior to
the delivery catheter 150 being removed.

[0064] In an embodiment, abrasively treating the external surface of the
expandable member 170 for example, by chemical etching or air propelled
abrasive media, improves the connection and adhesion between the external
surface of the expandable member 170 and a bone surface. The surfacing
significantly increases the amount of surface area that comes in contact
with the bone which can result in a stronger grip.

[0065] The expandable member 170 can be infused with light-sensitive
liquid 165 and the light-sensitive liquid 165 can be cured to form a
photodynamic implant the photodynamic implant may be separated from the
delivery catheter 150. As shown in FIG. 3A and FIG. 3B, a separation area
142 is located at the junction between the distal end of the cured
expandable member 170 (or photodynamic implant) and the delivery catheter
150 to facilitate the release of the photodynamic implant from the
delivery catheter 150. The separation area 142 ensures that there are no
leaks of reinforcing material from the elongated shaft of the delivery
catheter and/or the photodynamic implant. The separation area seals the
photodynamic implant and removes the elongated shaft of the delivery
catheter by making a break at a known or predetermined site (e.g., a
separation area). The separation area 142 may be various lengths and up
to about an inch long. The separation area 142 may also include a stress
concentrator, such as a notch, groove, channel or similar structure that
concentrates stress in the separation area 142. The stress concentrator
can also be an area of reduced radial cross section of cured
light-sensitive liquid inside a contiguous cross sectional catheter to
facilitate separating by the application of longitudinal force. The
stress concentrator is designed to ensure that the photodynamic implant
is separated from the delivery catheter 150 at the separation area 142.
When tension is applied to the delivery catheter 150, the photodynamic
implant separates from the shaft of the delivery catheter 150,
substantially at the location of the stress concentrator. The tension
creates a sufficient mechanical force to preferentially break the cured
material and catheter composite and create a clean separation of the
photodynamic implant/shaft interface. The photodynamic implant may be
separated from the delivery catheter 150 by any other suitable means
including, but not limited to, radial twisting, shear impact, and
cross-sectional cutting.

[0066] In an embodiment, the shape of the photodynamic implant corresponds
to the shape of the expandable member 170. In various embodiment, the
photodynamic implant can be pear-shaped, oval, round, elongated, tapered,
and the like. Modification of light-sensitive liquid 165 infusion allows
a user to adjust the span or thickness of expandable member 170 to
provide specific photodynamic implant size and shape to each subject. In
that the expandable member 170 is formable and shapeable by the user
prior to the photocuring of the light-sensitive liquid 165 in the
expandable member 170, the photodynamic implant best mirrors the size and
shape of the area into which the expandable member 170 is implanted. In
an embodiment, the photodynamic implant is configured to be at least
partially placed into a space within a head of a bone. In an embodiment,
the photodynamic implant is configured to be contained within a head of a
bone. In an embodiment, the photodynamic implant is configured such that
a distal section of the implant extends for a length into the shaft of
the bone.

[0067] In an embodiment, the photodynamic implant formed by infusing and
curing the light sensitive liquid 165 into the expandable member 170 is
used for restructuring, aligning and/or stabilizing a bone. In an
embodiment, the expandable member 170 can be infused with an amount of
light-sensitive liquid 165 such that the final cured photodynamic implant
has the size and shape to substantially return a broken head of a bone to
its anatomical shape. In an embodiment, the expandable member 170 can be
infused with an amount of light-sensitive liquid 165 such that the
photodynamic implant has the size and shape such that a head of a bone
can be restructured to a substantially original size and shape around the
final cured photodynamic implant. In an embodiment, the expandable member
170 can be infused with an amount of light-sensitive liquid 165 such that
the photodynamic implant facilitates a reduction of a fractured bone. In
an embodiment, the size and shape of the photodynamic implant 510
attempts to maximize the surface contact area with the surrounding bone,
minimizing specific points of concentrated pressure. The photodynamic
implant may be sufficiently designed to provide high compressive
strength, thus minimizing deformation under dynamic loading conditions.

[0068] In an embodiment, the expandable member is positioned and inflated
to a size sufficient to provide maximum fill of the cavity of the bone,
such as an intramedullary canal, at the region of the fracture or
weakened bone. The expandable member is inflated to any suitable size. In
an embodiment, the expandable member is inflated up to about 20 mm in
diameter.

[0069]FIG. 5 shows an embodiment of a photodynamic implant 510 that is
designed to engage other bone fixation implants 520 including, but not
limited to, bone screws, nails, pins and rods, among others. The bone
fixation implants can engage the final cured photodynamic implant at any
user-selected location along the photodynamic implant. For example, FIG.
5 illustrates a plurality of bone fixation implants 520 engaged with the
photodynamic implant 510 at user-selected locations 525. In an
embodiment, bone fragments can be secured in substantially original
position by attaching the bone fragments to the final cured photodynamic
implant with bone fixation implants. In an embodiment, the photodynamic
implant 510 can be placed into a space within a head of a bone and one or
more bone fixation implants can be inserted through the bone into the
photodynamic implant 510 so as to fixate the head to the rest of the
bone. In reference to FIG. 5, in an embodiment, the photodynamic implant
510 may include one or more receptacles 530 for receiving standard
metallic implants. In an embodiment, the photodynamic implant 510 may
include one or more receptacles 530 to engage an intramedullary nail or
rod 550. The nail or rod 550 may be secured to the photodynamic implant
510 by any suitable means such as, for example, locking, snap-fit,
friction fit or threading or similar.

[0070] In an embodiment, bone fixation implants including, but not limited
to, screws and other suitable mechanisms are anchored into the cured
expandable member or the photodynamic implant at the surgeons desired
locations based on the fracture pathology and not the location of
pre-determined locking holes. In an embodiment, the photodynamic implant
are of a sufficiently large size to provide for a significant anchor and
target above and below the fracture site for placement of multiple bone
fixation implants including support cross-locking screws and any other
suitable mechanisms.

[0071]FIG. 6 illustrates a device inserted into a cavity of bone using
the present systems and methods. First, a minimally invasive incision
(not shown) is made through the skin of the patient's body to expose a
fractured bone. The incision may be made at the proximal end or the
distal end of the fractured bone to expose the bone surface. Once the
bone is exposed, it may be necessary to retract some muscles and tissues
that may be in view of the bone. As shown in FIG. 6, an access hole 610
is formed in a bone 605 by drilling or other methods known in the art.
The access hole extends through a hard compact outer layer of the bone
into the relatively porous inner or cancellous tissue. For bones with
marrow, the medullary material should be cleared from the medullary
cavity prior to insertion of the system 100. Marrow is found mainly in
the flat bones such as hip bone, breast bone, skull, ribs, vertebrae and
shoulder blades, and in the cancellous material at the proximal ends of
the bones like the femur and humerus. Once the medullary cavity is
reached, the medullary material including air, blood, fluids, fat,
marrow, tissue and bone debris should be removed to form a void. The void
is defined as a hollowed out space, wherein a first position defines the
most distal edge of the void with relation to the penetration point on
the bone, and a second position defines the most proximal edge of the
void with relation to the penetration site on the bone. The bone may be
hollowed out sufficiently to have the medullary material of the medullary
cavity up to the cortical bone removed. Any suitable method for removing
the medullary material may be used. Suitable methods include, but are not
limited to, those described in U.S. Pat. No. 4,294,251 entitled "Method
of Suction Lavage," U.S. Pat. No. 5,554,111 entitled "Bone Cleaning and
Drying system," U.S. Pat. No. 5,707,374 entitled "Apparatus for Preparing
the Medullary Cavity," U.S. Pat. No. 6,478,751 entitled "Bone Marrow
Aspiration Needle," and U.S. Pat. No. 6,358,252 entitled "Apparatus for
Extracting Bone Marrow."

[0072] A guidewire 608 may be introduced into the bone 605 via the access
hole 610 and advanced through the intramedullary cavity 615 of the bone
602 to a rounded head 609 of the bone 602. The expandable member 170 of
the system 100 is then delivered over the guidewire 608 to be placed
within the head 609 of the bone 602. The location of the expandable
member 170 may be determined using at least one radiopaque marker 615
which is detectable from the outside or the inside of the bone 602. Once
the expandable member 170 is in the correct position within the head 609,
the light-sensitive liquid 165 is then infused into the expandable member
170 to cause the expandable member 170 to expand to a desired size and
shape, as described above.

[0073] The light-sensitive liquid 165 can be cured inside the expandable
member 170 using the light-conducting fiber 140, as shown in FIG. 3A.
After the light-sensitive liquid 165 is hardened, the light-conducting
fiber 140 can be removed from the system 100.

[0074] In an embodiment, an expandable member 170 is filled with the cured
light-sensitive liquid 165 that is released from the delivery catheter
150 to form a photodynamic implant inside the head 609 of the bone 602,
as shown in FIG. 3B. In an embodiment, a photodynamic implant of the
present disclosure acts to return a broken bone substantially to its
original, anatomical shape. In an embodiment, a photodynamic implant of
the present disclosure acts as a mandrel over which fragments of a broken
bone can be arranged to a substantially original position and to which
the fragments can be attached by using bone fixation implants, including,
but not limited to, bone screws, nails, pins and rods, among others. A
bone fixation implants can be placed into a photodynamic implant of the
present disclosure at any user-selected location on the photodynamic
implant. In an embodiment, a photodynamic implant of the present
disclosure is used for reattaching a bone fragment separated from a
broken bone. In an embodiment, a photodynamic implant of the present
disclosure is used to re-align fragments of a broken bone. In an
embodiment, a photodynamic implant of the present disclosure provides
support and stability to a fractured bone during the natural healing
process of the bone. In an embodiment, a photodynamic implant of the
present disclosure can be used to stabilize or add strength to a weakened
bone.

[0075] In an embodiment, the photodynamic implant provides rotational
stability by contouring to the cavity of the bone without the need for a
significant number of locking screws or other bone fixation mechanisms,
though such mechanisms may be used. Also, the expandable member is of a
sufficient size to provide bending stability.

[0076] In an embodiment, a bone implant system 100 of the present
disclosure is used to treat a fractured or weakened proximal humerus. In
general, proximal humeral fractures are classified based on the number
and type of major fragments. For example, a two-part fracture is
typically a humeral neck fracture, separating the head of the humerus
from the shaft of the humerus. More complicated fractures are three-part
and four-part fractures. Three-part proximal humerus fractures can
involve, for example, separation of greater tuberosity and humeral neck.
Four-part fractures typically involve articular surface of the head and
head splitting fractures. In an embodiment, a photodynamic implant of the
present disclosure can be used to treat two-part, three-part, or
four-part fractures of the proximal humerus. In an embodiment, a
photodynamic implant of the present disclosure can be used to realign,
restructure, stabilize or support the shaft of the humerus, greater
tuberosity, humeral neck, articular surface of the head and head
splitting fractures. In an embodiment, a photodynamic implant of the
present disclosure can be used to stabilize a weakened humeral head,
neck, shaft or other portions of humerus.

[0077] In an embodiment, access to the intramedullary cavity of a humerus
can be obtained by either retrograde approach or an antegrade approach as
described above. It should be noted that the orientation of the
expandable member relative to the delivery catheter will change depending
on the chosen approach. The expandable member 107 is placed within a
space of cancellous bone near the top of the humeral head. Once the
expandable portion 107 is in the correct position within the humerus, the
expandable portion 107 is filled with the light-sensitive liquid 165,
which is then cured resulting in the photodynamic implant 510. In an
embodiment, the bone implant system 100 is used to treat a humeral neck
fracture, separating the head of the humerus from the shaft of the
humerus. The addition of the light-sensitive liquid 165 to the expandable
member 170 causes the expandable member to expand. As the expandable
member 170 is expanded by the entering light-sensitive liquid 165, the
fracture of the humeral neck is reduced. Once orientation of the bone
fragments is confirmed to be in a desired position, the light-sensitive
liquid 165 can be cured to form the photodynamic implant 510, which can
then be separated from the delivery catheter. In an embodiment, the
photodynamic implant 510 is used to treat a three-part fracture or a
four-part fracture of a humeral head. In an embodiment, the photodynamic
implant 510 acts as a filler, mandrel or support element for fragments of
the humeral head. In an embodiment, the photodynamic implant 510 fills
the space within the humeral head to substantially return the hemural
head to its anatomical shape. In an embodiment, fractured bone fragments
can be placed over the photodynamic implant 510 to return the fragments
to their respective substantially original, anatomical positions. In an
embodiment, broken fragments can be secured in their respective
substantially, original position by attaching the broken fragments to the
photodynamic implant by bone fixation implants, such as bone screws,
nails, pins and rods, among others. In an embodiment, the photodynamic
implant 510 extends into the shaft of the humerus or is attached to
another implant that extends into the shaft of the humerus to provide
additional stability to the bone for the duration of the healing process.

[0078] In an embodiment, a bone implant system 100 of the present
disclosure is used to treat a proximal femoral fracture, such as a
femoral neck fracture. In an embodiment, a bone implant system 100 of the
present disclosure is used to treat or stabilize a weakened femoral head.

[0079] As shown in FIG. 7, in an embodiment, the photodynamic implant 710
is created inside an intramedullary space 704 within a head 706 of the
femur 702, as described above. The broken fragments of the femur 702 can
then be aligned and compressed together by placing a metal screw 708 or
another bone fixation implant through the bone fragments or the side of
the femur 702 into the photodynamic implant 710 in the femoral head 706.
The force of compression on the bone fragments can be controlled by
controlling the distance to which the screw 708 is driven into the
photodynamic implant 710. The combination of the photodynamic implant 710
and a secondary implant, i.e. the screw 708, provides strength and
stability to the femur 702. Alternatively or additionally, the
photodynamic implant 710 can be configured to fill interstitial space
between the bone fixation implant 708 and cortical bone surface inside
the intramedullary cavity 704 to distribute load more evenly across the
bone surface. That is, the photodynamic implant 710 acts as a filler
between the bone fixation implant 708 and the cortical bone surface so
that load is not transferred between the bone fixation implant 708 and
the cortical bone through focal contact points between the bone fixation
implant 708 and the cortical bone, but is rather distributed throughout a
conformal contact created by the photodynamic implant 710.

[0080] In an embodiment, the present device includes a series of small
interlocking metallic or plastic tubes that are inserted into the cavity
of the bone, such as the medullary canal. In an embodiment, the series of
tubes are used instead of or in addition to the use of the catheter The
tubes are made from any suitable material including, but not limited to,
a metal or a plastic. The tubes are interlocked sequentially to adjacent
tubes such that the addition of the each incremental tube lengthens the
entire tube.

[0081] In an embodiment, the tubes are slid over a mandrel and then locked
or engaged to an adjacent tube in an end to end fashion. The interlocking
mechanism of the sequential tubes is flexible so that the tubes can
accommodate curvatures and deflections within the cavity of the bone.
Since the series of tubes are flexible, the series of tubes are able to
transit the length of the cavity of the bone without being obstructed
within the canal as would a rigid length of tubing. Also, because the
tube is flexible, a larger diameter tube or series of tubes may be
interlocked and used within the cavity of a bone. A rigid tube would need
to have a smaller diameter to navigate the deflections and curvatures
within a cavity of a bone. The interlocking tubes may be of different
diameters such that the tubes can accommodate different diameters and
tapers within the cavity of the bone.

[0082] In an embodiment, once the tubes are all interlocked, the
photodynamic monomer and the expandable member are inserted into and
through the tube, the expandable member is inflated, and the photodynamic
monomer is cured within the confines of the tube. In an embodiment, the
use of the series of tubes and the monomer disposed within the series of
tubes provides a stronger photodynamic implant.

[0083] It should be noted that although the present disclosure has been
described with respect to treating fractures of the humerus and femur,
those skilled in the art will recognize that the presently disclosed
embodiments and methods can be used to treat other bones in the body,
including but not limited to, a fractured or weakened tibia, fibula,
ulna, radius, metatarsals, metacarpals, phalanx, phalanges, ribs, spine,
vertebrae, clavicle and other bones.

[0084] In an embodiment, a device for restructuring or stabilizing a
fractured or weakened head of a bone includes a delivery catheter having
an elongated shaft with a proximal end, a distal end, and a longitudinal
axis therebetween, the delivery catheter having an inner void for passing
at least one light sensitive liquid, and an inner lumen; an expandable
member releasably engaging the distal end of the delivery catheter, the
expandable member moving from a deflated state to an inflated state when
the at least one light sensitive liquid is passed to the expandable
member; wherein the expandable member is sufficiently designed to be at
least partially placed into a space within a head of a bone, and a light
conducting fiber sized to pass through the inner lumen of the delivery
catheter and into the expandable member, wherein, when the light
conducting fiber is in the expandable member, the light conducting fiber
is able to disperse the light energy to initiate hardening of the at
least one light sensitive liquid within the expandable member to form a
photodynamic implant.

[0085] In an embodiment, a method for repairing or stabilizing a fractured
or weakened head of a bone includes placing a expandable member removably
attached to a distal end of a delivery catheter into at least partially
into a space within a head of a bone, infusing a light sensitive liquid
into the expandable member through an inner lumen of the delivery
catheter, inserting a light conducting fiber into the expandable member
through an inner void of the delivery catheter, and activating the light
conducting fiber to cure the light sensitive liquid inside the expandable
member, thereby forming a photodynamic implant inside the head of the
bone which serves as a mandrel or form for repair and stabilization of
the head of the bone.

[0086] In an embodiment, a kit for repairing or stabilizing a fractured or
weakened head of a bone includes an light conducting fiber; a unit dose
of at least one light sensitive liquid; and a delivery catheter having an
elongated shaft with a proximal end, a distal end, and a longitudinal
axis therebetween, wherein the delivery catheter has an inner void for
passing the at least one light sensitive liquid into a expandable member
releasably engaging the distal end of the delivery catheter, and an inner
lumen for passing the light conducting fiber into the expandable member,
wherein the expandable member is sufficiently designed to be at least
partially placed into a space within a head of a bone. In an embodiment,
the kit includes a plurality of expandable members of different sizes or
shapes. In an embodiment, the kit includes a light source.

[0087] In an aspect, a device for restructuring or stabilizing a fractured
or weakened head of a bone includes: a delivery catheter having an
elongated shaft with a proximal end, a distal end, and a longitudinal
axis therebetween, an inner void for passing at least one light sensitive
liquid, and an inner lumen; an expandable member releasably engaging the
distal end of the delivery catheter; and a light conducting fiber sized
to pass through the inner lumen of the delivery catheter and into the
expandable member. The expandable member is capable of moving from a
deflated state to an inflated state when the at least one light sensitive
liquid is passed to the expandable member. The expandable member is
sufficiently designed to be at least partially placed into a space within
a head of a bone. When the light conducting fiber is in the expandable
member, the light conducting fiber is able to disperse the light energy
to initiate hardening of the at least one light sensitive liquid within
the expandable member to form a photodynamic implant

[0088] In one aspect, a method for repairing or stabilizing a fractured or
weakened head of a bone includes: placing an expandable member removably
attached to a distal end of a delivery catheter at least partially into a
space within a head of a bone; infusing a light sensitive liquid into the
expandable member through an inner lumen of the delivery catheter;
inserting a light conducting fiber into the expandable member through an
inner void of the delivery catheter; and activating the light conducting
fiber to cure the light sensitive liquid inside the expandable member to
form a photodynamic implant inside the head of the bone. In an
embodiment, the expandable member has a tapered elongated shape.

[0089] In one aspect, a kit for repairing or stabilizing a fractured or
weakened head of a bone includes: a light conducting fiber; at least one
light sensitive liquid; a delivery catheter having an elongated shaft
with a proximal end, a distal end, and a longitudinal axis therebetween,
an inner void, and an inner lumen; and an expandable member releasably
engaging the distal end of the delivery catheter. The expandable member
is sufficiently designed to be at least partially placed into a space
within a head of a bone. The delivery catheter has an inner void for
passing the at least one light sensitive liquid into the expandable
member, and an inner lumen for passing the light conducting fiber into
the expandable member. In an embodiment, the kits includes a plurality of
expandable members of different sizes or shapes. In an embodiment, the
kit includes a light source.

[0090] All patents, patent applications, and published references cited
herein are hereby incorporated by reference in their entirety. It will be
appreciated that several of the above-disclosed and other features and
functions, or alternatives thereof, may be desirably combined into many
other different systems or application. Various presently unforeseen or
unanticipated alternatives, modifications, variations, or improvements
therein may be subsequently made by those skilled in the art.